What is Bioethics and Law? : From the Korean Perspective

Kim, Hyeon-Chul Ewha Institute for Biomedical Law & Ethics 2010 BIOMEDICAL LAW & ETHICS Vol.4 No.1

Law and Bioethics is a relatively new academic area of dealing with a broad range of legal issues relevant to the biomedical ethics. This article first reviews the unique features of the Law and Bioethics as a special field of law. Legal topics in the Law and Bioethics are not limited to one specific area of a traditional field of law, such as criminal law, but cover almost all spheres of the legal phenomena. In addition, since the Law and Bioethics treats ethical issues raised in a very technical and highly specialized areas - life science and the medical science, legal reasoning in this area requires a certain level of knowledge on the scientific subjects as well as reflexive attitude towards legal and ethical conclusions. Considering these unique features of the Law and Bioethics, this article investigates the three regulation models: the model centered around regulations by law and rules, the model centered around administrative regulations, and the model centered around self-regulation. With specific examples, each model will be examined in the context of the Law and Bioethics.

개정생명윤리법에 따른 줄기세포연구의법적 쟁점

김현철 梨花女子大學校 法學硏究所 2012 法學論集 Vol.16 No.3

Korean Bioethics and Safety Law was enacted in 2005 and has been in force now. But this law was revised fully on last February this year and will be in force next year. This revision law modifies and compensates several problems of current law. The main issues of this revision include primary normative requests such as protocol peer review, human subject consent, protection of personal information and so on in human subject research and human material research. In fields of stem cell research, this revision regulates main issues almost the same as current law about the establishment of embryonic stem cell lines, embryonic stem cell research, somatic cell nuclear transfer research and so on. And new regulations of this revision include unisexual reproduction research, deletion of the importer’s obligation to register the imported stem cells and so on. Futhermore as human subject research and human material research will be regulated by this revision, new technology such as induced pluri potent stem cell research, spermatgonal stem cell research, adult stem cell research and clinical research of stem cell. But the provisions to regulate the usage of human eggs in somatic cell nuclear transfer research and unisexual reproduction research are insufficient. And I think there are needs to introduce the special committee such as ESCRO or SCRO to Bioethics and Safety Law in the future. 2005년에 제정된 “생명윤리 및 안전에 관한 법률(이하 생명윤리법)”이 지난 2012년 2월 1일 개정되어 2013년 2월 2일 시행을 앞두고 있다. 이 개정 생명윤리법은 기존 생명윤리법에서 문제가 되었던 부분을 수정하고 보완하고 있다. 특히 인간대상연구와 인체유래물연구에 대한 연구계획서 심의, 피험자 동의 등 기본적인 규범적 요청들을 입법화하여 많은 생명과학연구를 새롭게 규율하게 된 것은 가장 큰 특징이라 할 것이다. 이에 따라 기존 생명윤리법에서 규율대상이 아니었던 성체줄기세포연구나 역분화유도전분화능줄기세포, 정원줄기세포 등의 연구들이 인체유래물연구 혹은 인간대상연구의 범주에 속하게 되어, 각각의 연구에 특유한 규율은 아니지만 생명과학연구로서 최소한 갖추어야 할 규범적 요청들을 실현할 수 있도록 되었다. 그럼에도 불구하고 본문에서 지적하였듯이 체세포핵이식배아연구 혹은 단성생식배아연구 등에 사용되는 난자에 대한 규정이 미흡하다는 점, 배아줄기세포주를 이용하려는 자의 기관위원회에 대해 보다 명확하게 규율해 둘 필요가 있다는 점 등 몇 가지 점들은 향후 입법적으로 개선될 필요가 있을 것이다. 이 글은 이러한 문제점 외에도 줄기세포연구와 관련되어 전문적인 법해석이 필요한 부분을 도출하여 개인적인 해석론을 전개하였다. 이런 해석론은 이 주제에 대한 후속 연구가 이어질 수 있는 시작점이 될 것이라고 생각한다.

인체유래물의 이용과 형사법적 규제

최민영 대한의료법학회 2018 의료법학 Vol.19 No.3

Human biological material, defined in article 2 of Bioethics and Safety Act of Korea, has been regulated since 2012. However, we have little information about how human biological materials and how use of them are regulated under the Korean laws, specially under Criminal Law what features of existing regulations governing use of them, how those regulations should be and so. Considering this background, the study will briefly touch on basic concepts and classification of them. In the next chapter, it will examine and compare how use of human biological materials as well as biobanks are criminally regulated under “Bioethics and Safety Act” as well as other special laws - as such “Internal Organs, etc. Transplant Act”, “Safety, Management, etc. of Human Tissue Act”, “Blood Management Act”, “Act on Core Blood Management and Research”, and “Act on Dissection and Preservation of Corpses”, based on three types of acts. Lastly, the study will suggest future directions of regulation and criminal law. In fact, use of human biological material is closely related with other norms and regulations besides criminal laws and regulations. We, therefore, should consider issues and regulations involving use of human biological material from broader perspective beyond criminal laws. Nevertheless, it is required that related criminal provisions covering use of human biological material and biobank should be applied in a consistent way and defects or imperfection of those provisions should be dealt with. In addition, it is necessary to legislate new provisions in criminal procedures so as to prevent any misuse of biobank. 인체유래물은 2012년 이후부터 생명윤리법 제2조에서 정의되어 규율되고 있다. 그러나 인체유래물의 이용에 있어 법적 규제가 어떻게 이루어지고 있는지, 특히 형사법적 규제의 양상이 어떠하고, 어떠해야 하는지는 우리에게 아직까지 생소한 논의에 속한다. 이러한 배경에서 본 논문은 인체유래물의 개념과 분류를 짧게 개관하고, 생명윤리법을 비롯한 각각의 특별 법률 – 장기이식법, 인체조직법, 혈액관리법, 제대혈법, 시체해부법 – 이 인체유래물과 인체유래물은행의 이용을 형법적 측면에서 어떻게 규제하고 있는지를 행위유형별로 분석하여 비교검토하고, 그 규제의 방향을 전망한다. 결론적으로, 인체유래물 이용과 관련한 형법적 규제는 형법만이 아니라 다른 여러 법규범들과의 관계를 고려하며 유기적으로 이루어져야 한다. 단기적으로는 형사법의 틀 안에서 인체유래물과 인체유래물은행을 규율하는 각 법률 간의 체계적 일관성을 도모하고, 입법적 불비사항들을 재정비해야 할 것으로 보인다. 또한 형사절차상, 인체유래물은행의 이용과 관련한 기본원칙을 밝히고, 그 남용 및 오용을 규율하는 일반조항을 신설할 필요가 있다.

공법 : 배아와 인간존엄

방승주 ( Seung Ju Bang ) 한양대학교 법학연구소 2008 법학논총 Vol.25 No.2

As a result of the remarkable developments in biotechnology and biomedicine, it has become an important issue whether an embryo in vitro should be afforded human dignity and the right of life. In Korea, ``The Law of Bioethics and Safety`` was enacted to resolve conflicts between bioethics and biotechnology. Since section 17 of the law holds that supernumerary embryos, which elapsed more than 5 years of preservations-period or fewer than 5 years of this period, if the parents give consent, can be used in research for the treatment of sterility and contraceptive measures, muscle dystrophy, or a rare or incurable disease. Two embryos, their parents and other people (law professor, philosophers, doctors, lawyer etc.) have brought constitutional complaint against the law in the Constitutional Court, for the reason why the section violates their human dignity and the embryos` right of life. In this case, the most important points are whether an embryo could be the subject of human dignity and the right of life on the one hand, and whether sections 16 and 17 of the law violate human dignity and the right of life, as the embryos and other people including their parents articulated, on the other hand. There are many theories about when human dignity and the right of life begin: from the time of fertilization, implantation, building of the brain, development of the human shape, or birth, among other time points. In my opinion, the embryo is the subject of human dignity from the time of fertilization, even before it is implanted in the mother`s womb (fertilization`s theory). Nevertheless, from the perspective of the protect-intensity of human dignity, embryos before implantation could be treated differently than the embryo after implantation. In other words, the human dignity of the embryo before implantation could be restricted by the fundamental rights of the mother like the rights of self-decision (Article 10 Constitution). 배아와 인간존엄 37 The conclusions that follow from the recognition of embryos as the subject of human dignity and the possibility of restricting dignity-protection, which the author formed in this article, are as follows: First, except for the purposes of childbirth, supernumerary embryos in vitro should not be created. Second, nevertheless, in the case of creating supernumerary embryos according to the current law, the woman should not be obligated to implantation, if the woman no longer desires pregnancy. Third, if the woman dies or has no intention for childbirth while the supernumerary embryos are being preserved, the state should search the chances of implantation like a surrogate mother, for the purpose of protecting human dignity and the right of life. If not, the state should preserve the embryos permanently in principle until it finds the possibility of implantation. Fourth, the embryo not only should not be abolished, but also should not be used for research, even if the 5-year period of preservations has passed, lest the creation of embryos for research should be legalized in practice. Fifth, so-called "somatic cell nuclear transfer embryos" are also the subject of human dignity, because they could develop into a human being, on the condition that they would be transplanted into the wombs. Therefore, the creation of somatic cell nuclear transfer embryos should not be permitted, even if they are made for therapeutic purposes. In conclusion, sections 16 and 17 of the law, which prescribe that embryos should be abolished after 5 years or less period, if the parents consent to it, to be preserved, so that they may be used for research, are unconstitutional, because they violate the human dignity clause and the rights of life for embryos in vitro.

유럽의 인체유래물 연구에 있어서의 동의 및 면제제도-EU와 독일의 제도를 중심으로-

변무웅,최용전 유럽헌법학회 2019 유럽헌법연구 Vol.0 No.30

The emergence of precision medicine and personalized medicine inevitably requires the construction of a medical platform through expansion of large-scale analysis of genetic information, a population-based cohort, and human materials research. Therefore, activation of Consent and Consent Exemption is required within the scope of not invading the Self-Determination Right to medical information provider. Many laws, such as the Bioethics Act, Organs Transplant Act, Safety of the Human Tissue Act and Blood Management Act, is supposed to receive written consent includinf the objectives of research, procedure of research, foreseen risks and benefits of research, protection of personal information, preservation and discarding, withdrawal of consent, provision of personal information, etc. from the research participants and the donor. This is to respect the dignity and autonomy of the research participants and the donor. On the other hand, if it is determined that obtaining consent from a human subject of research is impracticable in the course of research or is likely to seriously affect the validity of research and if there is no ground to find that a human subject of research will decline consent or the risk to a human subject of research is very low even if the project is exempted from consent. a research project may be exempted from obtaining written consent of a human subject of research, subject to approval from the competent institutional committee. However, the 2019 revised Bioethics Act stipulates that a notice system, rather than a consent system, should be used to provide the human material bank with the remaining samples used by medical institutions. As long as the subject does not indicate rejection of the offer, a method that can be provided, that is, an opt-out method, has been introduced. The European Union has enacted the “DIRECTIVE 2004/23 / EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells” with a donor's consent and consent exemption system. And in EU, Seven countries are opting for the opt-in method, or the consent system(Zustimmungslösung), while 23 are opting for the opt-out method, or the contradiction system(Widerspruchlösung). Recently, the opt-out method has been expanded. Germany also enacted the 'Human Tissue Act(Gewebegesetz)' and accepted the European Union Directive 2004/23/EC as a domestic law. Germany has been adopting a "extended consent system(erweiterte Zustimmungslösung)." However, in 2019, the transplantation Act was revised to introduce an opt-out method, or an contradiction system for organ transplants of a deceased person. However, the expansion of the consent exemption system, including the notification system, and the expansion of the opt-out method in the donation or transplantation of organs of the deceased person greatly help human materials research. It is a great trend to create a good environment that can ensure the development of human materials research along with the guarantee of the right to personality. Therefore, in human subjectsor human materials research project, the opt-in method that personality rights can be well guaranteed can be widely applied to the research participation and organ donation and extraction. However, the opt-out method should be expanded within the scope of not infringing on the right of personality to improve the research environment of human materials research project. 정밀의료와 개인별 맞춤의료의 등장은 필연적으로 대규모 유전체 정보의 분석, 인구집단 코호트, 인체유래물연구 등의 확대를 통하여 의료플랫폼의 구축이 필요하게 되었다. 따라서 의료정보주체의 자기결정권을 침해하지 않는 범위 내에서 동의제도와 동의면제제도의 활성화가 요구되고 있다. 우리나라에서는 생명윤리법, 장기이식법, 인체조직법 등 많은 법률이 연구참여자와 기증자의 존엄성과 자율성에 근거하여, 연구목적, 연구와 관련된 기간과 절차, 연구와 관련된 이해득실, 개인정보의 보호와 제공, 검체의 보존과 폐기 등, 동의의 철회 그리고 제3자에의 제공 등을 내용으로 서면동의를 받고 있다. 한편, 연구대상자의 동의를 받는 것이 연구 진행과정에서 현실적으로 불가능하거나 연구의 타당성에 심각한 영향을 미친다고 판단되는 경우와 연구대상자의 동의 거부를 추정할 만한 사유가 없고, 동의를 면제하여도 연구대상자에게 미치는 위험이 극히 낮은 경우에는 기관위원회의 승인을 받아 연구대상자의 서면동의를 면제할 수 있도록 하고 있다. 그러나, 2019년 개정된 생명윤리법은 의료기관에서 진단과 치료에 사용한 잔여검체를 인체유래물은행에 제공하고자 할 때에는 동의제도가 아닌 고지제도를 도입하여, 대상자가 제공거부의사를 표시하지 않는 한, 제공될 수 있는 방식 즉 옵트아웃(opt-out) 방식이 도입되었다. 유럽연합은 “인간의 조직과 세포의 기증, 수집, 검사, 가공, 보관, 저장 및 배분에 관한 유럽연합 지침(Directive 2004/23/EC)”을 제정하여 기증자의 동의와 동의면제제도를 두고 있으며, 옵트인(opt-in) 방식 즉 동의방식이 7개국, 옵트아웃(opt-out) 방식 즉 항변방식을 택하고 있는 나라가 23개국으로서, 점차 옵트아웃 방식이 확대되고 있다. 독일도 ‘인체조직법률’을 제정하여 유럽연합 지침을 국내법률로 수용하였으며, 그동안 ‘확대형 동의방식’의 동의제도를 채택하고 있었으나, 2019년 이식법을 개정하여, 사자의 장기이식에 옵트아웃 방식 즉 ‘항변방식’을 도입하였다. 이와 같이 EU와 독일은 물론 우리나라에도 인체유래물을 인격권적 측면에서 보호하며, 연구대상자와 기증자의 자기결정권을 보장하고 있다. 그러나, 고지제도를 비롯한 동의면제제도의 확대, 사자의 기증 혹은 장기적출에 있어서 옵트아웃 방식의 확충은 인격권의 보장과 함께 인체유래물연구의 활발한 전개를 보장할 수 있는 환경을 조성하고자 하고자 하는 것이 큰 흐름이다. 따라서 우리나라에서도 인간대상 연구나 인체유래물 연구에 있어서는 연구참여와 장기의 기증과 적출에 인격권이 잘 보장될 수 있는 옵트인 방식이 폭넓게 적용될 수도 있다. 그렇지만, 인격권을 침해하지 않는 범위 내에서 옵트아웃 방식을 확충하여 인체유래물연구의 연구환경을 개선하여야 할 것이다.

생명윤리와 연구대상자 보호

손영화 한국법정책학회 2023 법과 정책연구 Vol.23 No.1

Since the beginning of this century, ethical guidelines for human research have been established, and ethical examinations have to be conducted when conducting human-targeted research and human-derived research. The Bioethics and Safety Act includes not only medical research, but also social science research and humanities research conducted through interaction with people who have nothing to do with natural science experiments. Depending on the field of study, the Bioethics Committee of the Organization is required to review papers and applications for research funds in academic journals. The history of human research ethics can be divided into three cases: the Nuremberg Code, the Helsinki Declaration made by the World Medical Association based on the Nuremberg Code, and the Belmont Report, which embodies the Helsinki Declaration. Although this bioethics originated from reflection on human experiments by the German Nazis, research bioethics have naturally been developed to respect human rights from reflection on inhumane and anti-ethical human experiments. Today, the Institutional Bioethics Committee is conducting tasks such as deliberating research plans, investigating ongoing research at the institution, supervising, educating, establishing measures to protect vulnerable research subjects, and preparing ethical guidelines for researchers. The deliberation focuses on the ethical and scientific validity of the research plan, whether consent has been obtained through due process, safety of research subjects, personal information protection measures for research subjects, and matters related to the bioethics and safety of institutions. Researchers who want to conduct human research must start research after obtaining approval from the Bioethics Committee, so they must apply for deliberation in accordance with the designated form of the Bioethics Committee. If the research is to be continued or there are any changes or violations or omissions during the course of the research, the relevant matters shall be deliberated, and when the research is completed, the research results report shall be submitted for deliberation. It is important to remember that the main focus of institutional bioethics is the protection of those under study. Therefore, researchers should eliminate the possibility of conflicts of interest in research. Furthermore, the safety of the individuals subject to the study should be fully taken into account and the risk should be minimized. Individuals and groups in vulnerable environments must be especially protected. Care should be taken to allow participants to participate voluntarily and not inflate economic benefits or reduce risks. In other words, when conducting human research and human-derived research, the participants must obtain voluntary consent to participate in the research. In addition, since protection of the subjects is important in human research, attention should be paid to protecting the personal information and guaranteeing confidentiality of the subjects. When planning, performing, or reporting research results, researchers should ensure that the basic ethical principles of Belmont Report 3 are met, such as respect for humans, good deeds, and justice, and comply with the basic principles and related arguments set out in Article 3 of the Bioethics and Safety Act. When we comply with the ethical principles and laws that human researchers must abide by, it should be remembered that scientific credibility of the results as well as the human rights, safety, and welfare of the study subjects is guaranteed. 금세기 들어 사람을 대상으로 하는 연구에 관한 윤리지침이 제정되어 인간대상연구 및 인체유래물연구를 하는 경우 윤리심사를 하지 않으면 안되게 되었다. 종래 대표적인 인간대상연구를 하던 의학 연구뿐 아니라 자연과학적인 실험과는 전혀 상관이 없는 사람과의 상호작용을 통해서 수행되는 사회과학 연구나 인문학 연구도 「생명윤리 및 안전에 관한 법률(이하, 생명윤리법)」의 규율 대상에 포함되게 된 것이다. 학문분야에 따라서는 학회지에 논문 투고나 연구비를 신청할 때도 기관생명윤리위원회의 심사가 요구되고 있다. 인간을 대상으로 한 연구윤리의 역사는 제2차 세계대전 중 인체실험을 계기로 한 '뉘른베르크 강령', 뉘른베르크 강령을 바탕으로 세계 의사회가 작성한 '헬싱키 선언', 그리고 헬싱키 선언을 보다 구체화한 '베르몬트 리포트'라는 3가지 사건으로 나눌 수 있다. 독일 나치의 인체실험의 반성에서부터 출발한 생명윤리이지만 비인간적, 반윤리적 인체실험에 대한 반성에서 자연스럽게 인권존중을 위한 방향으로 연구생명윤리가 형성되고 발전되었다고 할 것이다. 오늘날 기관생명윤리위원회는 연구계획서의 심의, 해당 기관에서 진행중인 연구에 대한 조사, 감독, 교육, 취약한 연구대상자 보호대책 수립, 연구자를 위한 윤리지침 마련 등의 업무를 수행하고 있다. 심의는 연구계획서의 윤리적·과학적 타당성, 적법한 절차에 의한 동의 획득을 받았는지의 여부, 연구대상자 등의 안전, 연구대상자 등의 개인정보 보호대책, 기관의 생명윤리 및 안전에 관한 사항 등에 초점을 두어 심의하고 있다. 인간대상연구를 하고자 하는 연구자는 반드시 기관생명윤리위원회의 승인을 받은 후 연구를 시작하여야 하므로 소속 기관생명윤리위원회의 지정된 양식에 따라 심의를 신청하여 일정한 심의과정을 의무적으로 거쳐야 한다. 만약, 연구 수행 중에 연구를 지속하고자 하거나 변경 사항 또는 위반, 이탈이 있다면 해당 사항에 대하여 심의를 받아야 하며, 연구 종료 시에는 연구결과보고서를 제출하여 심의를 받아야 한다. 기관생명윤리는 무엇보다도 연구대상자의 보호에 그 주안점이 있음을 기억할 필요가 있다. 그러므로 연구자는 연구에 있어서 이해충돌 가능성을 없애야 한다. 또한 연구에 있어서 연구대상자의 안전을 충분히 고려하고 위험은 최소화하여야 한다. 취약한 환경에 있는 개인이나 집단은 특별히 보호되어야 한다. 연구대상자가 자발적으로 참여할 수 있도록 하며, 경제적인 이익을 부풀리거나 위험을 축소하지 않도록 주의해야 한다. 다시 말해, 인간대상연구와 인체유래물연구를 수행할 때에는 반드시 대상자 본인으로부터 연구참여에 대한 자발적 동의를 받아야 한다. 또한, 인간대상연구에서는 연구대상자에 대한 보호가 중요하므로 연구대상자의 개인정보보호와 비밀보장이 되도록 주의를 기울여야 한다. 연구자는 연구의 계획, 수행, 결과보고를 하는 경우 벨몬트 보고 3 기본윤리원칙인 인간존중, 선행, 정의에 맞도록 하고, 생명윤리법 제3조에 제시된 기본원칙과 관련 주장을 잘 준수하여야 한다. 인간대상연구의 연구자가 지켜야 할 윤리원칙과 법률을 잘 지킬 때 연구대상자의 인권, 안전, 복지가 보장됨은 물론 연구결과에 대한 과학적 신뢰성이 확보될 수 있음을 잊지 말아야 할 것이다.

「생명윤리 및 안전에 관한 법률」 전부개정안의 내용과 의의 : 임상연구와의 관계를 중심으로

김은애 대한의료법학회 2011 의료법학 Vol.12 No.1

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject’s information confidentiality and the human subject’s privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

IRB와 HRPP의 개념과 운영에 대한 제언

신희영 (재) 국가생명윤리정책원 2022 생명, 윤리와 정책 Vol.6 No.2

A hospital is a place where clinical trials are conducted in accordance with the Phar- maceutical Affairs Law, and human subject research is performed in accordance with the Bioethics and Safety Act. In accordance with the Bioethics and Safety Act and the Phar- maceutical Affairs Law, the Institutional Review Board (IRB) is integrated and operated within the institution to protect human subjects. In addition, domestic clinical trials have recently been activated and have increased rapidly in a relatively short period of time. As a result, as part of a comprehensive development plan to position the country as a leader in clinical trials, the Ministry of Food and Drug Safety (MFDS) has implemented the Korean model of the Human Research Protection Program (HRPP) through operational guidelines. Although the term IRB is widely known in relation to research ethics, the term HRPP has only been in use for a relatively short period of time. However, there appears to be confusion surrounding the concept of HRPP, as multiple understandings coexist. In order to help understand and operate HRPP compared to the IRB, the relat- ed content is summarized in comparison to the situation in the United States, and the following suggestions are made. First, it is necessary to harmonize and reach a consensus with the stakeholders regarding the relationship between the IRB and the HRPP. Second, it is required to consult and cooperate with the Ministry of Health and Welfare and the MFDS on the IRB and HRPP. Third, it is necessary to discuss the future direction of the Korean model of HRPP promoted by the MFDS.

보조생식술 관련 영국 HFEA 동의서식의 내용과 의의 : 자기결정권 보장 및 생식물질 관리 관련 내용을 중심으로

김은애 이화여자대학교 생명의료법연구소 2012 생명윤리정책연구 Vol.6 No.2

The informed consent of the person related to using the assisted reproductive technology is very important to protect their right to self determination and to manage their gamete and embryo. So, the Korean Ministry of Health & Welfare has offered the informed consent form as the official form through the enforcement rule of Bioethics and Safety Act and its guidebook. Also, the UK HFEA(Human Fertilisation and Embryology Authority) has offered all informed consent form related to using the assisted reproductive technology officially. The UK consent form is very useful to both the institution and the right holder because the form is appropriately classified considering the different kinds of the way to treat the infertility such as the artificial insemination or in vitro fertilization, the additional use of donor’s gamete/embryo, the involvement of surrogate mother as well as the position of different parties such as the woman directly involved, her spouse, the gamete/embryo donor. And the contents of UK consent form is abundant to confirm the consent holder’'s decision, so the institution is able to manage the consent holder’'s gamete/embryo accurately. The completely revised Bioethics and Safety Act will enforce from the next year. So, the Korean Ministry of Health & Welfare is preparing the draft of amended enforcement rule of Bioethics and Safety Act including the official form related to using the assisted reproductive technology. I hope that the Korean Ministry of Health & Welfare takes the opportunity to improve the Korean consent form considering the advantage or strength of the UK consent form for stronger protection of he right to self determination and more exhaustive management of the human gamete and embryo.

한국에서의 인공수정관련법의 입법동향과 법체계상의 올바른 입법방식

송영민 원광대학교 법학연구소 2009 圓光法學 Vol.25 No.3